Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 5, refs. 513, 514, 523 – 525 were not found in the Written Description. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, “transmitting data from” should read “transmitting the data from” to better clarify that the data from line 7 is the same as the data from line 12.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “first anchoring device” and “second anchoring device” in claims 2 and 16 and “energy receiving element” in claim 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding the anchoring devices, Fig. 5b best shows the anchoring devices to be substantially pin shaped. Therefore, the structure determined sufficient to perform the function of anchoring is a pin or functional equivalent thereof
Regarding the energy receiving element, paragraph [0075] discloses a pick-up coil ref. 430 configured to receive energy from an external hand-help source. Therefore, the structure determined sufficient to perform the function of receiving energy is a pick-up coil or functional equivalent thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 - 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bilger et al. (US 2015/0105834 A1) in view of Hunter (US 2004/0152972 A1).
Regarding claim 1, Bilger discloses a method of treating a curvature of a spine of a patient using an implantable device (Abstract, Figs. 6a-b, paragraph [0067) comprising the steps of:
providing the implant device (paragraph [0067], ref. 502), the implant device including:
an implant body (ref. 12, paragraph [0040] and seen used on the spine in Figs. 6a-b),
an actuator coupled to the implant body (ref. 80, Fig. 4 and paragraph [0050], refs. 91, 92),
a sensor disposed adjacent to the implant body (ref. 125, Fig. 4, paragraph [ 0054]),
a transceiver configured to transmit data to an external remote control and receive instructions from the external remote control (paragraph [0033] discloses an external control and paragraph [0033] discloses control signals, taken to be the instructions, which are wirelessly transmitted to the device via the transceiver ref. 106, Fig. 4),
a controller (paragraph [0054], ref. 124);
detecting, via the sensor, a measurable parameter indicative of a biological condition (paragraph [0054] discloses sensing elongation and/or movement of the device and spine, which are considered to be measurable parameters of a biological condition),
adjusting the implant via the actuator (paragraph [0057]).
Bilger is silent regarding a memory disposed within the implant body and coupled to the controller and is silent regarding the step of
transmitting data from the transceiver to the external remote control, the data being associated with the measurable parameter and
adaptively adjusting the actuator, via the controller, in response to the measurable parameter detected by the sensor, information stored in the memory, and the instructions received from the external remote control.
It is noted that Bilger does disclose a two-way information conduit between the device and a remote system, see Fig. 4, ref. 106. Paragraph [0072] discloses transmitting data to the external remote control wirelessly for the controlling the implant body. However, the specific limitations of the transmitting data from the sensor to the external remote control and then adaptively adjusting the implant based upon the measurable parameter from the sensor is not disclosed.
Hunter teaches a method for post-operative tuning of a spinal implant comprising an implant body (ref. 52, Figs. 8F – 8G, paragraph [0096] which discloses any type of spinal disc implant for any area of the spine), a memory disposed within the device (paragraph [0127] discloses a memory for storing data), sensors (paragraph [0092], ref. 58, Fig. 8A),
transmitting data from a transceiver to an external remote control the data being associated with the measurable parameter (Fig. 10, refs. 236, 242, 240, paragraph [0101] discloses the step of transmitting data to an external remote control, such as a computer and user, where the data is from the sensor and analyzed by the external remote control, note that these steps are disclosed as pre-operative and operative. For post-operative adjustment see Fig. 10, refs. 248, 250, 256, 258, 262, 264 and paragraphs [0105 - 115) and
adaptively adjusting the implant (Fig. 10, ref. 262), in response to the data detected by the sensor (ref. 262), information stored in the memory (such as the pre-operative data and other patient information), and instructions received from the external remote control (paragraphs [0111-115] discloses a determination of adjustment which are considered to be the instructions).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bilger to include the memory disposed within the implant body and coupled to the controller,
transmitting data from the transceiver to the external remote control, the data being associated with the measurable parameter and
adaptively adjusting the actuator, via the controller, in response to the measurable parameter detected by the sensor, information stored in the memory, and the instructions received from the external remote control, wherein the actuator adjusts the implant body, as taught by Hunter, for the purposes of minimizing undesirable performance characteristics during patient healing time (paragraph [0104]).
Regarding claim 2, Bilger in view of Hunter discloses the method of claim 1, wherein the implant body further includes a first anchoring device configured to couple the implant body to a first vertebra, and a second anchoring device configured to couple the implant body to a second vertebra (Bilger, paragraph [0067], Fig. 6a-b, refs. 502, 503).
Regarding claim 3, Bilger in view of Hunter discloses the method of claim 2, wherein the first vertebra and the second vertebra are adjacent vertebrae (Bilger, Fig. 6a, paragraph [0067])).
Regarding claim 4, Bilger in view of Hunter discloses the method of claim 2, wherein the first vertebra and the second vertebra are non-adjacent vertebrae (Bilger, paragraph [0067]).
Regarding claim 5, Bilger in view of Hunter discloses the method of claim 2, wherein the adaptively adjusting the actuator includes applying compression between the first anchoring device and the second anchoring device (Bilger, paragraph [0062] discloses compression).
Regarding claim 6, Bilger in view of Hunter discloses the method of claim 2, wherein the adaptively adjusting the actuator includes applying force to lengthen the distance between the first anchoring device and the second anchoring device (Bilger, paragraph [0062] discloses distraction, thus lengthening).
Regarding claim 7, Bilger in view of Hunter discloses the method of claim 1, wherein the biological condition is a herniated lumbar disc (Bilger, paragraph [0068]).
Regarding claim 8, Bilger in view of Hunter discloses the method of claim 1, wherein the information the memory stores includes at least one of data associated with the measurable parameter, data associated with the instructions received from the external remote control, and status information (Hunter, paragraph [0127] discloses data associated with the sensor, and thus the measurable parameter).
Regarding claim 9, Bilger in view of Hunter discloses the method of claim 2, wherein the measurable parameter is a distance between the first anchoring device and the second anchoring device (Hunter, paragraph [0057] discloses tacking the distance between the targeted vertebrae via the sensors).
Regarding claim 10, Bilger in view of Hunter discloses the method of claim 2, wherein the measurable parameter is a motion between the first anchoring device and the second anchoring device (Hunter, paragraph [0057] discloses tracking articulating bones, thus motion).
Regarding claim 11, Bilger in view of Hunter discloses the method of claim 1, wherein the measurable parameter is at least one of blood flow, temperature, strain, pH, stress, bone composition, bone mass, bone density, bone thickness, bone perfusion, bone strength, bone oxygenation, electrical conductivity, and a presence of active media (Hunter, paragraph [0100] discloses temperature, strain and other force motions).
Regarding claim 12, Bilger in view of Hunter discloses the method of claim 1, further comprising a power supply (Bilger, paragraphs [0051-52]).
Regarding claim 13, Bilger in view of Hunter discloses the method of claim 12, wherein the power supply is configured to be charged by the external remote control (Bilger, paragraph [0052]).
Regarding claim 14, Bilger in view of Hunter discloses the method of claim 1, further comprising an energy receiving element (Bilger, ref. 123) configured to receive energy from an external source (paragraph [0052]).
Regarding claim 15, Bilger discloses a method of treating a curvature of a spine of a patient using an implantable device (Abstract, Figs. 6a-b, paragraph [0067), comprising the steps of:
measuring a measurable parameter indicative of a biological condition using the implantable device (paragraph [0054] discloses sensing elongation and/or movement of the device and spine, which are considered to be measurable parameters of a biological condition based upon sensors ref. 125);
transmitting instructions from the external remote control to the implantable device (paragraph [0033] discloses an external control and paragraph [0033] discloses control signals, taken to be the instructions, which are wirelessly transmitted to the device via a transceiver ref. 106, Fig. 4);
a controller (ref. 124, Fig. 4)
but is silent regarding the steps of
processing the measurable parameter using a controller disposed in the implantable device;
transmitting data associated with the measurable parameter from the implantable device to an external remote control;
adjusting the implantable device in response to the measurable parameter, treatment information stored in memory in the implantable device, and the instructions received from the external remote control.
It is noted that Bilger does disclose a two-way information conduit between the device and a remote system, see Fig. 4, ref. 106. Paragraph [0072] discloses transmitting data to the external remote control wirelessly for the controlling the implant body. However, the specific limitations of the transmitting data from the sensor to the external remote control and then adaptively adjusting the implant based upon the measurable parameter from the sensor is not disclosed.
Hunter teaches a method for post-operative tuning of a spinal implant comprising an implant body (ref. 52, Figs. 8F – 8G, paragraph [0096] which discloses any type of spinal disc implant for any area of the spine), a memory disposed within the device (paragraph [0127] discloses a memory for storing data), sensors (paragraph [0092], ref. 58, Fig. 8A) for measuring a measurable parameter (paragraph [0109] discloses a variety of different measurable parameters, such strain, tress and temperature),
processing the measurable parameter (paragraph [0110]);
transmitting data associated with the measurable parameter from the implantable device to an external remote control (Fig. 10, refs. 236, 242, 240, paragraph [0101] discloses the step of transmitting data to an external remote control, such as a computer and user, where the data is from the sensor and analyzed by the external remote control, note that these steps are disclosed as pre-operative and operative. For post-operative adjustment see Fig. 10, refs. 248, 250, 256, 258, 262, 264 and paragraphs [0105 - 115) and
adjusting the implantable device in response to the measurable parameter (Fig. 10, ref. 262), treatment information stored in memory in the implantable device (paragraph [0127]), and the instructions received from the external remote control (paragraphs [0111-115] discloses a determination of adjustment which are considered to be the instructions).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bilger to include the memory and the steps of processing the measurable parameter using a controller disposed in the implantable device;
transmitting data associated with the measurable parameter from the implantable device to an external remote control;
adjusting the implantable device in response to the measurable parameter, treatment information stored in memory in the implantable device, and the instructions received from the external remote control, as taught by Hunter, for the purposes of minimizing undesirable performance characteristics during patient healing time (paragraph [0104]).
Regarding claim 16, Bilger in view of Hunter discloses the method of claim 15, further comprising:
prior to the measuring of the measurable parameter, anchoring the implant device to a first vertebra using a first anchoring device, and anchoring the implant device to a second vertebra using a second anchoring device (Bilger shows the implant being anchored to the vertebra via a first and second anchoring device, refs. 502, 503 and in view of Hunter, who teaches a post-operative analysis, the combine method would require the anchoring device to be implanted prior to measuring the parameter).
Regarding claim 17, Bilger in view of Hunter discloses the method of claim 16, wherein measuring the measurable parameter comprises measuring a distance between the first anchoring device and the second anchoring device (Hunter, paragraph [0057] discloses tacking the distance between the targeted vertebrae via the sensors, thus Bilger as modified by Hunter discloses this step).
Regarding claim 18, Bilger in view of Hunter discloses the method of claim 16, wherein the first vertebra and the second vertebra are adjacent vertebrae (Bilger, paragraph [0067]).
Regarding claim 19, Bilger in view of Hunter discloses the method of claim 16, wherein the first vertebra and the second vertebra are non-adjacent vertebrae (Bilger, paragraph [0067]).
Regarding claim 20, Bilger in view of Hunter discloses the method of claim 15, wherein the biological condition is a herniated lumbar disc (Bilger, paragraph [0068]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 which lists the prior art used in the current rejection and other pertinent art teaches implantable devices and sensor communication.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773